CN114681151A - Suture length adjusting system capable of being adjusted quantitatively - Google Patents

Abstract

The invention provides a suture length adjusting system capable of being adjusted quantitatively, which comprises an adjusting assembly, wherein the adjusting assembly comprises a first adjusting piece and a second adjusting piece, the second adjusting piece is connected to the first adjusting piece in an axially movable mode, the first adjusting piece is provided with a first positioning part, and the second adjusting piece is provided with a second positioning part corresponding to the first positioning part. The suture line penetrates through the first adjusting piece and the second adjusting piece, the second adjusting piece moves relative to the first adjusting piece along the axial direction to the far end to push the suture line, the length of the suture line between the first adjusting piece and the second adjusting piece is increased until the first positioning portion is matched with the second positioning portion, and therefore the second adjusting piece is limited to move relative to the first adjusting piece. This suture length control system, simple structure, convenient operation can realize the quantitative regulation of suture length, does not exert fixed pressure to the suture moreover in accommodation process, is favorable to avoiding the suture damage.

Description

Suture length adjusting system capable of being adjusted quantitatively

Technical Field

The invention belongs to the technical field of medical instruments, and particularly relates to a suture length adjusting system capable of being adjusted quantitatively.

Background

Mitral insufficiency is one of the most common heart valve diseases at present, and the main causes are rheumatic heart disease, mitral valve myxoid degeneration, ischemic heart disease, cardiomyopathy and the like, which cause the pathological changes of valve rings, valve leaflets, chordae tendineae and papillary muscles in the mitral valve structure, and further cause the valve leaflets of the mitral valve to be incapable of being completely closed.

Surgery is an effective method for treating mitral insufficiency, but the surgery causes great trauma to human bodies, and has more complications and higher mortality rate for elderly patients and patients with more complications.

At present, minimally invasive interventional surgery is the more preferable choice for most heart diseases, and the main interventional therapy modes include artificial chordae tendineae implantation, mitral valve annuloplasty, mitral valve rim-to-rim repair and the like. The artificial chordae tendineae implanted on the valve leaflets can effectively treat mitral insufficiency caused by chordae tendineae fracture, valve leaflet prolapse and the like, and meanwhile, the physiological integrity of the mitral valve structure is kept. However, after the artificial chordae are implanted for a period of time, the implanted artificial chordae are in a loose state due to changes of factors such as heart volume, and the like, the length of the artificial chordae often needs to be adjusted again, and the effective length of the artificial chordae is shortened to avoid the abnormal function of the heart valve.

In the prior art, an artificial chordae length adjusting device is disclosed, which comprises a hook for capturing the artificial chordae, an instrument for stretching the artificial chordae, a stretching amount for determining the length to be adjusted, and two positioning clamps for fixing the artificial chordae to achieve the effect of adjustment and control. The main drawbacks of this technique are: 1. the regulation and control instrument is too complex, and the operation difficulty is high; 2. the extrusion force of the clamp is easy to damage the artificial chordae tendineae; 3. quantitative regulation and control cannot be performed, and the regulation and control amount is unstable. These problems all lead to the risk of surgical failure or ineffective control in artificial chordal regulation.

Disclosure of Invention

In order to solve the technical problems, the invention provides a suture length adjusting system capable of being adjusted quantitatively, which is simple in structure and convenient to operate, can realize quantitative adjustment of suture length, and can avoid suture damage in the adjusting process.

The invention provides a suture length adjusting system capable of being adjusted quantitatively, which comprises an adjusting assembly, wherein the adjusting assembly comprises a first adjusting piece and a second adjusting piece, the second adjusting piece is connected to the first adjusting piece in an axially movable manner, the first adjusting piece is provided with a first positioning part, and the second adjusting piece is provided with a second positioning part corresponding to the first positioning part; the suture passes through the first adjusting piece and the second adjusting piece, the second adjusting piece moves relative to the first adjusting piece along the axial direction to the far end to push the suture, the length of the suture between the first adjusting piece and the second adjusting piece is increased until the first positioning part is matched with the second positioning part, and therefore the relative movement between the second adjusting piece and the first adjusting piece is limited.

According to the suture length adjusting system capable of being adjusted quantitatively, after a suture penetrates between the first adjusting piece and the second adjusting piece, the second adjusting piece moves to the far end along the axial direction relative to the first adjusting piece to push the suture, so that the length of the suture between the first adjusting piece and the second adjusting piece is increased to adjust the suture, quantitative adjustment of the length of the suture can be achieved by controlling the moving amount of the second adjusting piece relative to the first adjusting piece, and the whole system is simple in structure and convenient to operate; moreover, in the process of adjusting the suture, the second adjusting piece does not apply fixing pressure on the suture, so that the suture is prevented from being damaged; in addition, after the quantitative adjustment of the suture is completed, the first positioning part and the second positioning part are matched to limit the second adjusting piece to move relative to the first adjusting piece, so that the suture is prevented from loosening.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings needed to be used in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and it is obvious for those skilled in the art to obtain other drawings based on these drawings without creative efforts.

Fig. 1 is a schematic diagram of the overall structure of a suture length adjusting system capable of being adjusted quantitatively according to one embodiment of the present invention.

Fig. 2 is a schematic perspective view of the adjusting assembly and the conveying assembly shown in fig. 1.

Fig. 3 is a partial axial cross-sectional view of the adjusting assembly and the conveying assembly shown in fig. 2, wherein the second limiting member is accommodated in the second accommodating cavity and corresponds to the second positioning portion.

FIG. 4 is a schematic view of the second adjusting member shown in FIG. 3 axially moved distally relative to the first adjusting member until the first detent portion mates with the second detent portion.

Fig. 5 is a schematic view of the first and second adjusting members shown in fig. 4 with a pushed suture passing therebetween.

Fig. 6 is a perspective view of the adjustment assembly shown in fig. 4.

Fig. 7 is an axial cross-sectional view of the adjustment assembly shown in fig. 6.

Fig. 8 is a perspective view of the first adjusting member shown in fig. 6.

FIG. 9 is a proximal end elevational view of the first adjustment member illustrated in FIG. 8.

Fig. 10 is a structural view of the second regulating member shown in fig. 6.

Fig. 11 is a right side view of the second adjustment member shown in fig. 10.

Fig. 12 is a schematic view of the release member shown in fig. 3.

Fig. 13 is an axial cross-sectional view of the release member shown in fig. 12.

Fig. 14 is a distal end elevational view of the release member illustrated in fig. 12.

Fig. 15 is a schematic perspective view of the first limiting member shown in fig. 3.

Fig. 16 is an axial sectional view of the first retaining member shown in fig. 15.

Fig. 17 is a distal end elevational view of the first retaining member illustrated in fig. 15.

Fig. 18 is a perspective view of the connection shaft shown in fig. 3.

Fig. 19 is a schematic perspective view of the connecting shaft, the releasing member, the second limiting member and the connecting member shown in fig. 3.

Fig. 20 is an axial cross-sectional view of the connecting shaft, the release member, the second stopper, and the connecting piece shown in fig. 19.

Fig. 21-23 are schematic illustrations of the use of the present invention to provide a quantitatively adjustable suture length adjustment system.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be obtained by a person skilled in the art without inventive effort based on the embodiments of the present invention, are within the scope of the present invention.

Furthermore, the following description of the various embodiments refers to the accompanying drawings, which illustrate specific embodiments in which the invention may be practiced. Directional phrases used in this disclosure, such as "upper," "lower," "front," "rear," "left," "right," "inner," "outer," "side," and the like, refer only to the direction of the appended figures and, therefore, are used in a better and clearer sense to describe and understand the present invention rather than to indicate or imply that the device or element so referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus should not be considered limiting of the present invention.

It is to be noted that, in order to describe more clearly the structure of the suture length adjustment system which can be adjusted quantitatively, the terms "proximal" and "distal" are used herein as terms customary in the field of interventional medicine. Specifically, "distal" refers to the end of the surgical procedure that is distal from the operator, and "proximal" refers to the end of the surgical procedure that is proximal to the operator; the direction of a rotating central shaft of an object such as a column body, a pipe body and the like is defined as an axial direction; the circumferential direction is the direction around the axis of an object such as a column, a pipe body and the like (perpendicular to the axis and the radius of the section); radial is the direction along a diameter or radius. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terminology used in the description of the invention herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention.

Referring to fig. 1 to 5, the present invention provides a suture length adjusting system 1 capable of quantitative adjustment, including an adjusting assembly 20, the adjusting assembly 20 includes a first adjusting member 21 and a second adjusting member 22 axially movably connected to the first adjusting member 21, wherein the first adjusting member 21 is provided with a first positioning portion 211, and the second adjusting member 22 is provided with a second positioning portion 221 corresponding to the first positioning portion 211. The suture 2 is inserted between the first adjusting part 21 and the second adjusting part 22, and the second adjusting part 22 moves axially and distally relative to the first adjusting part 21 to push the suture 2, so that the length of the suture 2 between the first adjusting part 21 and the second adjusting part 22 increases until the first positioning part 211 and the second positioning part 221 are fitted, thereby limiting the relative movement between the second adjusting part 22 and the first adjusting part 21. It will be appreciated that the second adjustment member 22 is moved axially distally different distances relative to the first adjustment member 21, and that the suture 2 is pushed a different distance, thereby varying the length of suture 2 that is adjusted. Specifically, as shown in fig. 5, after the suture 2 is pushed by the second adjusting member 22, the suture 2 between the first adjusting member 21 and the second adjusting member 22 is bent into an inverted U shape or a "zigzag" shape, and the adjusted length H of the suture 2 is approximately equal to twice the length H of the suture 2 on each side of the second adjusting member 2 in the radial direction of the first adjusting member 21, that is, H and H satisfy the relation: h is 2H, wherein the length H of the suture 2 on each side of the second adjusting member 2 in the radial direction of the first adjusting member 21 is the distance that the second adjusting member 22 moves towards the far end in the axial direction relative to the first adjusting member 21, so that quantitative adjustment of the length of the suture 2 can be realized by controlling the moving amount of the second adjusting member 22 relative to the first adjusting member 21.

According to the suture length adjusting system 1 capable of being adjusted quantitatively, after the suture 2 penetrates between the first adjusting piece 21 and the second adjusting piece 22, the second adjusting piece 22 moves towards the far end along the axial direction relative to the first adjusting piece 21 to push the suture 2, so that the length of the suture 2 between the first adjusting piece 21 and the second adjusting piece 22 is increased to adjust the suture 2, and quantitative adjustment of the length of the suture 2 can be achieved by controlling the moving amount of the second adjusting piece 22 relative to the first adjusting piece 21, the whole system is simple in structure and convenient to operate; moreover, during the process of adjusting the suture 2, the second adjusting piece 22 does not apply a fixing pressure on the suture 2, which is beneficial to avoiding the damage of the suture 2; further, after the quantitative adjustment of the suture 2 is completed, the cooperation of the first positioning portion 211 and the second positioning portion 221 can restrict the second adjusting member 22 from moving relative to the first adjusting member 21, thereby preventing the suture 2 from loosening.

It should be noted that the suture 2 may be a suture as an artificial chordae, such as an e-PTFE suture or a PET suture, the suture 2 is pushed by the second adjusting member 22 to adjust the length of the suture 2, that is, to adjust the effective length of the artificial chordae, and after the quantitative adjustment of the suture 2 is completed, the adjusting component 20 is clamped on the suture 2 and is left in the human body as an implant. In order to ensure the implantation safety, the first adjusting part 21 and the second adjusting part 22 may be made of a metal material or a polymer material with good biocompatibility, such as stainless steel or PEEK, and the materials of the first adjusting part 21 and the second adjusting part 22 may be the same or different.

As shown in FIG. 1, the suture length adjustment system 1 further comprises a delivery assembly 40 connected to the proximal end of the adjustment assembly 20, wherein the delivery assembly 40 is used for delivering the adjustment assembly 20 into the human body and controlling the relative movement between the first adjustment member 21 and the second adjustment member 22, and a handle assembly 60 connected to the proximal end of the delivery assembly 40, wherein the handle assembly 60 is used for allowing the operator to control the delivery assembly 40 outside the human body.

Specifically, referring to fig. 6 to 8, the first adjusting member 21 is a hollow substantially cylindrical body, and is provided with a first receiving cavity 212 extending along the axial direction, the first receiving cavity 212 at least penetrates through the proximal end surface of the first adjusting member 21, so that the second adjusting member 22 is inserted into the first receiving cavity 212 from the proximal end of the first adjusting member 21 in an axially sliding manner. Preferably, in this embodiment, the first accommodating cavity 212 penetrates the distal end surface of the first adjusting member 21 together, which is beneficial to reduce the weight of the first adjusting member 21; furthermore, the first receiving cavity 212 penetrates through the distal end surface of the first adjusting member 21, so that the second adjusting member 22 can move axially and distally relative to the first adjusting member 21 until the distal end of the second adjusting member 22 protrudes beyond the distal end of the first adjusting member 21, which is beneficial to increasing the distance that the second adjusting member 22 moves axially and distally relative to the first adjusting member 21, and further increasing the adjusted length H of the suture 2. Of course, in other embodiments, the first receiving cavity 212 may not penetrate through the distal end surface of the first adjusting member 21, as long as the depth of the first receiving cavity 212 along the axial direction of the first adjusting member 21 is enough to provide the moving space of the second adjusting member 22.

It should be noted that the inner contour of the first receiving cavity 212 is substantially the same as the outer contour of the second adjusting member 22, so that the second adjusting member 22 is movably received in the first receiving cavity 212.

Referring to fig. 7 to 10, a pair of guiding and sliding surfaces 213 are oppositely disposed on an inner wall of the first accommodating cavity 212, and the first positioning portion 211 includes at least one engaging groove opened on the at least one guiding and sliding surface 213, the engaging groove extends along a substantially radial direction of the first adjusting member 21; the second adjusting member 22 includes a pair of outer wall surfaces 222 corresponding to the pair of guiding and sliding surfaces 213 one by one, and the second positioning portion 221 includes an elastic hook disposed on at least one of the outer wall surfaces 222, and the elastic hook is clamped into a corresponding one of the clamping grooves to stop the relative movement between the second adjusting member 22 and the first adjusting member 21. Preferably, in this embodiment, the sliding surface 213 and the corresponding outer wall surface 222 are both arc surfaces, and when the second adjusting member 22 moves in the axial direction in the first accommodating cavity 212, the sliding contact between the sliding surface 213 and the outer wall surface 222 is smoother. Of course, in other embodiments, the sliding guide surface 213 and the corresponding outer wall surface 222 may be both planar.

In this embodiment, the pair of guiding sliding surfaces 213 are both provided with the clamping grooves, and the pair of outer wall surfaces 222 are both provided with the elastic hooks, so that the elastic hooks on the two opposite sides of the second adjusting member 22 can be clamped into the corresponding clamping grooves to limit the relative movement between the first adjusting member 21 and the second adjusting member 22, and the reliability is higher.

In the pair of sliding guide surfaces 213, the position of the engaging groove on one sliding guide surface 213 may or may not correspond to the position of the engaging groove on the other sliding guide surface 213, that is, the position of the engaging groove on one sliding guide surface 213 in the axial direction of the first adjusting member 21 is the same as or different from the position of the engaging groove on the other sliding guide surface 213 in the axial direction of the first adjusting member 21. In this embodiment, the slot positions of the pair of guiding and sliding surfaces 213 correspond to each other.

In this embodiment, one slot is provided on each sliding guide surface 213. It can be understood that when one slot is provided on each sliding guide surface 213, the elastic hook on the outer wall 222 corresponding to the sliding guide surface 213 can only be clamped into the one slot to limit the relative movement between the first adjusting member 21 and the second adjusting member 22, that is, the distance that the second adjusting member 22 moves axially and distally relative to the first adjusting member 21 is a fixed value, and the length H of the suture 2 that can be quantitatively adjusted is unique. Optionally, in other embodiments, the plurality of (i.e., two or more) clamping grooves may be formed in each of the sliding guide surfaces 213, the plurality of clamping grooves are distributed on the sliding guide surface 213 along the axial direction of the first adjusting member 21, the elastic clamping hook on the outer wall surface 212 corresponding to the sliding guide surface 213 provided with the plurality of clamping grooves can be clamped into one of the clamping grooves at different axial positions of the first adjusting member 21, so that the distance value of the second adjusting member 22 moving axially and distally relative to the first adjusting member 21 is multiple, and the length H of the suture 2 that can be adjusted quantitatively has multiple values, which is beneficial to enhancing the application range of the suture length adjusting system 1, and further beneficial to reducing the weight of the first adjusting member 21 by providing a plurality of clamping grooves.

Each of the locking grooves may extend in the radial direction of the first adjusting member 21 to penetrate through the outer wall of the first adjusting member 21 or not, preferably, penetrate through the outer wall of the first adjusting member 21, which is beneficial to reducing the weight of the first adjusting member 21 more.

In this embodiment, the spacing direction of the pair of sliding guide surfaces 213 is defined as a first direction, and a gap is provided between the inner wall of the first receiving cavity 212 and the second adjuster 22 in a second direction substantially perpendicular to the first direction, the gap being configured to receive the suture 2 between the inner wall of the first receiving cavity 212 and the second adjuster 22, so as to prevent the suture 2 from being damaged by compression. Specifically, referring to fig. 5, fig. 6 and fig. 9, in the present embodiment, a groove is formed on an inner wall of each side of the first accommodating cavity 212 in the second direction, the groove penetrates the first adjusting piece 21 along the axial direction, a depth of the groove (i.e., a dimension along the second direction) is not less than a diameter of the suture 2, when the second adjusting piece 22 is accommodated in the first accommodating cavity 212 and pushes against the suture 2, the suture 2 between an outer wall of the second adjusting piece 22 and the inner wall of the first accommodating cavity 212 is accommodated in the groove, so that the suture 2 can be prevented from being damaged by extrusion. In other embodiments, the groove may be opened on an outer wall of each side of the second adjusting member 22 in the second direction, or an inner wall of each side of the first accommodating cavity 212 in the second direction and an outer wall of each side of the second adjusting member 22 in the second direction are respectively opened with a groove to accommodate the suture 2 between the outer wall of the second adjusting member 22 and the inner wall of the first accommodating cavity 212, so as to prevent the suture 2 from being damaged by squeezing.

As shown in fig. 8, in this embodiment, the outer wall of the first adjusting member 21 is opened with a first open slot 214 communicating with the first accommodating cavity 212 from the proximal end surface, the first open slot 214 extends substantially along the axial direction of the first adjusting member 21, and the positions of the first open slot 214 and the locking slot on the inner wall of the first accommodating cavity 212 in the circumferential direction of the first adjusting member 21 are mutually staggered. The first slot 214 is used for passing the suture 2 in and out, and when the second adjusting member 22 pushes the suture 2, the first slot 214 can prevent the suture 2 from moving along the radial direction of the first adjusting member 21, and avoid the suture 2 from being separated from the space between the first adjusting member 21 and the second adjusting member 22. Optionally, as shown in fig. 6 and 7, in this embodiment, at least one hollow hole 216 is further formed in an outer wall of the first adjusting member 21, so as to further reduce the weight of the first adjusting member 21. The extending direction of each hollow hole 216 may be the same as or different from the extending direction of the slot of the first adjusting member 21, and each hollow hole 216 may be communicated with or not communicated with the first accommodating cavity 212. In this embodiment, each hollow hole 216 extends in the same direction as the slot and is connected to the first receiving cavity 212, so that the hollow holes 216 can also function as the slot.

Further, referring to fig. 3, fig. 7 and fig. 8, in the present embodiment, the first adjusting member 21 is provided with at least one threaded hole extending along the axial direction from the proximal end surface to one side of the first receiving cavity 212, for detachably connecting with the distal end of the driving rod 45 in the conveying assembly 40. The driving rod 45 is used for conveying the first adjusting piece 21, and the axial movement of the driving rod can drive the first adjusting piece 21 to move axially, so that the first adjusting piece 21 and the second adjusting piece 22 are driven to move axially relatively, the hooking and the ejection of the suture 2 are realized, and the quantitative adjustment of the length of the suture 2 is further realized; furthermore, after the quantitative adjustment of the length of the suture 2 is completed, the driving rod 45 can be detached from the first adjusting member 21, so that the first adjusting member 21 is detained in the human body.

Referring to fig. 7, 10 and 11, the second adjusting member 22 is a hollow block body, and has a second accommodating cavity 223 extending along the axial direction, the second accommodating cavity 223 at least penetrates through the proximal end surface of the second adjusting member 22, at least one outer wall surface 222 of the second adjusting member 22 is opened with an opening 224 communicating with the second accommodating cavity 223 at the proximal end area, and the second positioning portion 221 (i.e., the elastic hook) is disposed at the opening 224. In this embodiment, two outer wall surfaces 222 of the second adjusting member 22 on two opposite sides are respectively provided with an opening 224, and each opening 224 is provided with one of the elastic hooks.

Specifically, as shown in fig. 11, in the present embodiment, the elastic hook includes a spring piece and a buckle connected to a proximal end of the spring piece, a distal end of the spring piece is connected to a distal edge of the opening 224, and the buckle includes a stop surface facing a proximal end of the second adjusting member 22 and an inclined plane facing an outer side of the second adjusting member 22 and facing a distal end of the second adjusting member 22. The elastic sheet is made of elastic materials so as to ensure the elastic deformation capacity of the elastic sheet. It should be noted that, in this embodiment, in an initial state, the elastic hook of the second adjusting member 22 is located outside the distal end of the first adjusting member 21, and when the second adjusting member 22 moves axially and distally relative to the first adjusting member 21, the elastic hook first abuts against the proximal end surface of the first adjusting member 21, at this time, the inner wall of the proximal end opening edge of the first accommodating cavity 212 will abut against the inclined plane of the buckle, so as to force the proximal end of the elastic piece to bend towards the second accommodating cavity 223, so that the second adjusting member 22 can move axially and distally relative to the first adjusting member 21 until the elastic hook is accommodated in the first accommodating cavity 212; when the second adjusting member 22 continues to move axially and distally relative to the first adjusting member 21 until the position of the buckle corresponds to the slot position of the first adjusting member 21, the inner wall of the first accommodating cavity 212 does not abut against the buckle any more, and the elastic piece recovers deformation to allow the buckle to be clamped into the corresponding slot; it will be appreciated that, in reaction to the pushed suture 2, the second adjustment member 22 tends to move axially and proximally relative to the first adjustment member 21, and the stop surface of the catch abuts the groove surface of the slot, thereby limiting the axial and proximal movement of the second adjustment member 22 relative to the first adjustment member 21 and preventing the suture 2 from loosening.

In the present embodiment, as shown in fig. 10, the distal end surface of the second adjusting member 22 is opened with a radial slot 225 corresponding to the first slot 214 of the first adjusting member 21, both ends of the radial slot 225 respectively penetrate through the outer wall of the second adjusting member 22, and the radial slot 225 is used for accommodating and passing the suture 2 at the distal end of the second adjusting member 22. Preferably, the radial slots 225 are radiused to ensure that the radial slots 225 are smooth to avoid damaging the suture 2.

Further, referring to fig. 3, 6 and 10, in the present embodiment, the proximal end of the second adjustment member 22 is provided with a first connection portion 226 for detachably connecting with the distal end of the delivery member 43 in the delivery assembly 40. The conveying piece 43 is used for conveying the second adjusting piece 22 and limiting the axial position fixation of the second adjusting piece 22 when the driving rod 45 drives the first adjusting piece 21 to move along the axial direction, so that the relative movement between the first adjusting piece 21 and the second adjusting piece 22 along the axial direction can be realized, the hooking and the pushing of the suture 2 can be realized, and the quantitative adjustment of the length of the suture 2 can be further realized; after the quantitative adjustment of the length of the suture 2 is completed, the carrying member 43 can be detached from the second adjusting member 22, so that the second adjusting member 22 can be left in the human body together with the first adjusting member 21.

Specifically, as shown in fig. 6, in this embodiment, the first connecting portion 226 is a pair of first barbs disposed at the proximal end of the second adjusting member 22, the pair of first barbs are integrally connected to the outer wall 222 of the second adjusting member 22, and each of the first barbs has a first combining surface. It should be noted that when the second adjusting member 22 is received in the first receiving cavity 212, the first connecting portion 226 is located outside the distal end of the first adjusting member 21.

Referring to fig. 3, the conveying assembly 40 includes the conveying member 43 and the driving member 45. The conveying member 43 and the driving member 45 are flexible rods, tubes or cables having a certain axial length, a certain supporting property and a flexible property, and are made of a metal material or a polymer material having good biocompatibility, preferably a metal material such as stainless steel. In this embodiment, the conveying member 43 is a stainless steel cable, the driving rod 45 is a rod body made of stainless steel, the distal end of the driving rod 45 is provided with an external thread adapted to the internal thread of the threaded hole of the first adjusting member 21, and the driving rod 45 is in threaded connection with the first adjusting member 21.

Wherein the number of the driving rods 45 is equal to the number of the threaded holes. In this embodiment, the pair of threaded holes is opened on the first adjusting part 21, the two corresponding driving rods 45 are provided, and the first adjusting part 21 is driven to move along the axial direction through the pair of driving rods 45, so that the improvement of the stability of the movement of the first adjusting part 21 along the axial direction is facilitated, and the first adjusting part 21 can be prevented from rotating in the moving process.

Referring also to fig. 3, 12-14, in this embodiment, delivery assembly 40 further includes a release member 47 removably coupled to the distal end of delivery member 43, release member 47 being adapted to removably couple with second adjustment member 22. That is, in this embodiment, the distal end of delivery member 43 is removably coupled to second adjustment member 22 by release member 47.

Specifically, as shown in fig. 12 to 14, in the present embodiment, the releasing member 47 is a block-shaped structure, and includes a blocking portion 472 with a waist-circular shape at a distal end, an embedding portion 474 connected to the distal end of the blocking portion 472, and a pair of second barbs disposed at the distal end of the blocking portion 472, the pair of second barbs being respectively located at two opposite sides of the embedding portion 474, and the pair of second barbs being detachably connected to the pair of first barbs at the proximal end of the second adjusting member 22. Each second barb is provided with a second combining surface matched with the first combining surface of the first barb, the first combining surface and the second combining surface are S-shaped curved surfaces with certain curvature, and the curvatures of the first combining surface and the second combining surface are matched. It is understood that the axial movement of the conveying member 43 can move the releasing member 47 axially relative to the second adjusting member 22, so that the second connecting portion 476 can be detachably connected to or separated from the first connecting portion 226. When the first barb of the first connecting portion 226 and the second barb of the second connecting portion 476 are in the connected state, the conveying member 43 can be used for conveying the second adjusting member 22 and for limiting the axial position of the second adjusting member 22. In this embodiment, when the first barb and the second barb are in the connected state, the stopping portion 472 of the releasing member 47 is stopped at the proximal end of the first barb, and the embedding portion 474 of the releasing member 47 is embedded between the pair of first barbs.

The releasing member 47 is also made of a metal material or a polymer material with good biocompatibility, and preferably a metal material such as stainless steel.

Further, referring to fig. 2, fig. 3 and fig. 15 to fig. 17, in the present embodiment, the delivery assembly 40 further includes an outer sheath 49 and a first limiting member 41 connected to a distal end of the outer sheath 49, the outer sheath 49 is a hollow tube body for the delivery member 43 and the driving member 45 to pass through, and the first limiting member 41 is used for limiting the separation of the first connecting portion 226 of the second adjusting member 22 from the second connecting portion 476 of the releasing member 47. The outer sheath 49 and the first limiting member 41 may be made of a metal material or a polymer material with good biocompatibility, and preferably made of a metal material such as stainless steel.

Specifically, as shown in fig. 2 and 3, in the present embodiment, the first limiting member 41 includes a main body portion 414 having a columnar structure and a sleeve portion 415 connected to a proximal end of the main body portion 414, the sleeve portion 415 is a hollow substantially cylindrical body, and a distal end of the outer sheath 49 is fixedly connected to the sleeve portion 415 of the first limiting member 41 by any one of a clamping, an adhesion, or a welding. The body 414 and the socket 415 may be integrally formed, or may be separately formed and fixedly connected by any means such as laser welding, bonding, or clamping, and preferably laser welding.

Referring to fig. 3, 16 and 17, the main body 414 has a limiting groove 410 formed on a distal end surface thereof, a first through hole 411 formed on a bottom surface of the limiting groove 410 and extending in the axial direction for the distal end of the conveying element 43 to pass through, and at least one second through hole 412 formed on one side of the limiting groove 410 and extending in the axial direction for the distal end of the at least one driving element 45 to pass through on the main body 414. In this embodiment, the number of the second through holes 412 and the number of the driving members 45 are both two.

The axial line of the limiting groove 410 and the axial line of the first limiting member 41 have a radial distance therebetween, that is, the limiting groove 410 is eccentrically disposed at the distal end of the main body 414 of the first limiting member 41. It should be noted that, in this embodiment, the shape of the limiting groove 410 is adapted to the shape of the releasing member 47, and when the outer sheath 49 moves in the axial direction to drive the first limiting member 41 to move in the axial direction, so that the connecting portion between the first connecting portion 226 of the second adjusting member 22 and the second connecting portion 476 of the releasing member 47 is received in or moved out of the limiting groove 410, the first connecting portion 226 and the second connecting portion 476 can be connected or separated, that is, the second adjusting member 22 and the releasing member 47 can be connected or separated.

In the present embodiment, as shown in fig. 16, the main body 414 further has a protrusion 416 protruding from the edge of the distal end surface, the protrusion 416 extends along the circumferential direction of the first limiting member 41, and preferably, the protrusion 416 extends along the circumferential direction of the first limiting member 41 for one turn. As shown in fig. 3, in the present embodiment, under the driving of the driving rod 45, the first adjusting member 21 moves axially and proximally relative to the second adjusting member 22 to abut against the distal end surface of the main body 414 of the first limiting member 41. It can be understood that, the protrusion 416 has a certain height in the axial direction of the first limiting member 41, after the suture 2 is inserted into the first slot 14 of the first adjusting member 21, in the process that the first adjusting member 21 moves axially and proximally relative to the second adjusting member 22, the proximal end portion of the first adjusting member 21 will gradually penetrate into the space enclosed by the protrusion 416 until the proximal end surface of the first adjusting member 21 abuts against the distal end surface of the main body portion 414, that is, the protrusion 416 can gradually surround the proximal end portion of the first adjusting member 21 extending from the proximal end surface to the distal end surface by a certain distance, so as to enclose a gap between the proximal end surface of the first adjusting member 21 and the distal end surface of the main body portion 414 before the first adjusting member 21 abuts against the main body portion 414, so as to prevent the gap from catching human tissue and avoid damaging human tissue. Preferably, in this embodiment, the protrusion 416 has a second slot 417 corresponding to the first slot 214 of the first adjusting member 21, so that when the first adjusting member 21 abuts against the distal end surface of the main body 414, the first slot 214 and the second slot 417 together form a through hole for accommodating the suture 2 hooked by the first adjusting member 21.

Further, referring to fig. 3, in order to prevent the first slot 214 from not passing the suture 2 (i.e. the first adjusting member 21 does not hook the suture 2), the second adjusting member 22 is moved to be accommodated in the first accommodating cavity 212 and the elastic hooks are locked into the corresponding slots, in this embodiment, the conveying assembly 40 further includes a second limiting member 42 connected to the distal end of the conveying member 43, the conveying member 43 is further configured to drive the second limiting member 42 to move axially toward the distal end until the second limiting member 42 is received in the second receiving cavity 223 and corresponds to the position of the elastic hook, the elastic hook is bent toward the second accommodating cavity 223 to stop the proximal end of the first accommodating cavity 212 when the second adjusting member 22 moves axially and distally relative to the first adjusting member 21, so as to prevent the second adjusting member 22 from being accommodated in the first accommodating cavity 212 too early.

Specifically, referring to fig. 3, fig. 13 and fig. 18 to 20, in the present embodiment, a connecting shaft 46 is fixedly disposed at a distal end of the conveying element 43, a third through hole 478 (as shown in fig. 13) axially penetrating and having an internal thread is further formed in the releasing element 47 corresponding to the first through hole 411 of the first limiting element 41, the distal end of the conveying element 43 is threadedly connected to the releasing element 47 through the connecting shaft 46, the distal end of the connecting shaft 46 extends out from the distal end of the releasing element 47, and the second limiting element 42 is fixedly disposed at the distal end of the connecting shaft 46.

As shown in fig. 18, in the present embodiment, the connection shaft 46 includes a proximal shaft segment 462, an intermediate shaft segment 464 and a distal shaft segment 466 connected in sequence from the proximal end to the distal end, and the diameters of the proximal shaft segment 462, the intermediate shaft segment 464 and the distal shaft segment 466 are reduced in sequence, wherein the proximal shaft segment 462 is provided with a through hole along the axial direction from the proximal end surface for connecting the distal end of the delivery member 43, and the intermediate shaft segment 464 is provided with an external thread adapted to the internal thread of the third through hole 478 of the releasing member 47. As shown in fig. 19 and fig. 20, in the embodiment, the second limiting member 42 is a block-shaped spacer provided with a connecting hole, the second limiting member 42 is sleeved on the distal shaft segment 466 of the connecting shaft 46, and the proximal end surface of the second limiting member 42 abuts against the shaft shoulder between the middle shaft segment 464 and the distal shaft segment 466 of the connecting shaft 46, and the outer contour of the second limiting member 42 is adapted to the inner contour of the second accommodating cavity 223, so as to be inserted into the proximal end of the second accommodating cavity 223 to stop the elastic hook. In this embodiment, the distal end of the second limiting member 42 is further provided with a connecting sheet 48, the connecting sheet 48 is provided with a through hole along the axial direction, the connecting sheet 48 is sleeved on the distal shaft segment 466 of the connecting shaft 46 and located at the distal end of the second limiting member 42, and the connecting sheet 48 is fixedly connected with the connecting shaft 46, so that the second limiting member 42 is fixed on the connecting shaft 46. In other embodiments, the second limiting member 42 may be directly and fixedly connected to the connecting shaft 46, and the connecting shaft 46 may be integrated with the conveying member 43. The second limiting member 42, the connecting shaft 46 and the connecting piece 48 may be made of a metal material or a polymer material with good biocompatibility, and preferably, a metal material such as stainless steel is used. The connection between the connecting shaft 46 and the conveying member 43 and the connection between the connecting piece 48 and the connecting shaft 46 may be made by any means such as laser welding, bonding, clamping, interference, and the like, preferably laser welding.

Referring to fig. 3 and fig. 4, in the present embodiment, the second connecting portion 476 of the releasing member 47 and the first connecting portion 226 of the second adjusting member 22 are adapted to be placed in the limiting groove 410 of the first limiting member 41, when the conveying member 43 is rotated, the rotation of the conveying member 43 drives the connecting shaft 46 to rotate, under the limiting action of the limiting groove 410, the releasing member 47 cannot rotate, so that the connecting shaft 46 and the releasing member 47 move in a threaded manner, and the connecting shaft 46 moves in an axial direction relative to the releasing member 47 and drives the second limiting member 42 to move in an axial direction. Therefore, when the second limiting member 42 moves to the far end to be accommodated in the near end of the second accommodating cavity 223 of the second adjusting member 22 and corresponds to the position of the elastic hook, the outer side surface of the second limiting member 42 abuts against one side of the elastic hook facing the second accommodating cavity 223, so that the elastic hook is limited from bending and deforming towards the second accommodating cavity 223, when the first adjusting member 21 moves to the near end under the driving of the driving member 45, the near end port of the first accommodating cavity 212 of the first adjusting member 21 presses the inclined plane of the elastic hook, at this time, the elastic hook is abutted by the second limiting member 42 and cannot elastically deform, the elastic hook cannot be clamped into the clamping groove of the first adjusting member 21, and the second adjusting member 22 cannot be completely accommodated in the first accommodating cavity 212; when the conveying element 43 is controlled to drive the second limiting element 42 to move proximally to leave the inner cavity of the second receiving cavity 223 of the second adjusting element 22, the elastic hook of the second adjusting element 22 recovers the elastic deformation capability, at this time, if the first adjusting element 21 continues to move proximally, the proximal end opening of the first receiving cavity 2122 of the first adjusting element 21 partially presses the inclined plane of the elastic hook, the elastic hook bends toward the second receiving cavity 223, the first adjusting element 21 can move proximally relative to the second adjusting element 22, so that the second adjusting element 22 is completely received in the first receiving cavity 212 until the elastic hook is clamped into the corresponding clamping groove, thereby limiting the axial movement between the first adjusting element 21 and the second adjusting element 22, and the first adjusting element 21 and the second adjusting element 22 are locked together.

Referring to FIG. 1, in this embodiment, to facilitate manipulation of the delivery assembly 40 by an operator outside the body, the quantitatively adjustable suture length adjustment system 1 further includes a handle assembly 60 attached to the proximal end of the delivery assembly 40. Specifically, as shown in fig. 1, the handle assembly 60 includes a first knob 61, a second knob 62, a third knob 63, and a housing 64, the housing 64 is fixedly connected to the proximal end of the sheath 49, the first knob 61 is disposed at the proximal end of the housing 64, the second knob 62 is disposed in the middle of the housing 64, and the third housing 63 is disposed at the distal end of the housing 64.

As shown in FIG. 2, in this embodiment, the proximal ends of the delivery member 43 and the driving member 45 respectively extend from the proximal end of the outer sheath 49 and into the housing 64, and are connected to the corresponding knobs. Specifically, in the present embodiment, the first knob 61 is connected to the proximal end of the driving member 45, and is used for controlling the driving member 45 to move along the axial direction, so as to drive the first adjusting member 21 to open and close relative to the second adjusting member 22; the second knob 62 is connected to the proximal end of the driving member 45 and is used for controlling the driving member 45 to rotate, so as to separate the driving member 45 from the first adjusting member 21; a third knob 63 is coupled to the proximal end of delivery member 43 for controlling the axial movement of delivery member 43 and for controlling the rotation of delivery member 43 to drive the axial movement of second limiting member 42. It should be noted that, the connection between the first knob 61 and the second knob 62 and the driving member 45, and the connection between the third knob 63 and the conveying member 43 are implemented by using the prior art, and are not described herein again.

Referring to fig. 3, 4 and 21 to 23, the operation of the suture length adjusting system 1 according to the present embodiment will be described with reference to the drawings, taking the suture 2 as an artificial chordae tendineae implanted into a human body as an example.

The first step is as follows: as shown in fig. 21, the adjustment assembly 20 at the distal end of the suture length adjustment system 1 is delivered to the vicinity of the suture 2 as an artificial chordae through a guiding device (not shown) such as an adjustable curved sheath or a pre-shaped catheter.

The second step is that: as shown in FIG. 22, the driving member 45 is controlled by the first knob 61 of the handle assembly 60 to move axially and distally, and the driving member 45 drives the first adjusting member 21 to move distally, so that the first adjusting member 21 is opened relative to the second adjusting member 22 and the suture 2 is hooked, and at the same time, the suture 2 is inserted into the first slot 214 of the first adjusting member 2.

The third step: the medical imaging equipment is used for observing whether the first adjusting part 21 successfully hooks the suture 2, and after the suture 2 is observed to be successfully hooked, the conveying part 43 is controlled to rotate by the third knob 63 of the handle assembly 60, and the conveying part 43 rotates relative to the releasing part 47 to drive the second limiting part 42 to move towards the proximal end to move out of the proximal end of the second accommodating cavity 223 of the second adjusting part 22, so that the second limiting part 42 does not limit the deformation capacity of the elastic hook.

The fourth step: as shown in fig. 4 and 23, the driving member 45 is controlled by the first knob 61 to move axially and proximally to drive the first adjusting member 21 to move proximally, so that the second adjusting member 22 is accommodated in the first accommodating cavity 212, and the distal end of the second adjusting member 22 pushes the suture 2, so that the suture 2 is bent to be in an inverted U shape, thereby completing the adjustment of the suture 2, i.e. reducing the effective length of the artificial chordae tendineae, so that the originally loosened artificial chordae tendineae are tensioned again after being adjusted. At this time, the elastic hook of the second adjusting member 22 is snapped into the snap groove of the first adjusting member 21, so that the axial movement between the first adjusting member 21 and the second adjusting member 22 is limited, and the adjusted suture 2 is prevented from loosening.

The fifth step: controlling the driving member 45 to rotate by the second knob 62 of the handle assembly 60 to release the connection between the driving member 45 and the first adjusting member 21, so that the first adjusting member 21 is separated from the driving member 45; then, the third knob 63 controls the conveying element 43 to move axially and distally, and the conveying element 43 drives the releasing element 47 to move distally to move out of the limiting groove 410 of the first limiting element 41, so as to release the connection between the first connecting portion 216 of the second adjusting element 22 and the second connecting portion 476 of the releasing element 47, so that the second adjusting element 22 is separated from the releasing element 47, and at this time, the adjusting assembly 20 is completely released from the conveying assembly 60.

And a sixth step: the delivery assembly 60 and the guide device are withdrawn from the body and the adjustment assembly 20 is left as an implant in the patient and attached to the suture 2, completing adjustment of the suture 2.

In the adjustment process of the suture 2, the effective length of the suture 2 can be adjusted only by controlling the corresponding knob to rotate, so that the operation is convenient, and the time is saved; moreover, the second adjusting piece 22 realizes the adjustment of the suture 2 through the pushing and ejecting action, so that the suture 2 is hardly damaged, and the safety of the instrument is high; furthermore, by controlling the amount of movement of the second adjusting member 22 relative to the first adjusting member 21, and thus the distance by which the second adjusting member 22 pushes against the suture 2, quantitative adjustment of the length of the suture 2 can be achieved.

The foregoing is illustrative of embodiments of the present invention, and it should be noted that modifications and adaptations to those skilled in the art may be made without departing from the principles of the embodiments of the present invention and are intended to be within the scope of the present invention.

Claims (17)

1. A quantitatively adjustable suture length adjustment system comprising an adjustment assembly, the adjustment assembly comprising:

the first adjusting piece is provided with a first positioning part; and

the second adjusting piece is axially movably connected with the first adjusting piece, and a second positioning part is arranged corresponding to the first positioning part;

the suture passes through the first adjusting piece and the second adjusting piece, the second adjusting piece moves relative to the first adjusting piece along the axial direction to the far end to push the suture, the length of the suture between the first adjusting piece and the second adjusting piece is increased until the first positioning part is matched with the second positioning part, and therefore the relative movement between the second adjusting piece and the first adjusting piece is limited.

2. The quantitatively adjustable suture length adjustment system of claim 1, wherein the first adjustment member is hollow and is provided with a first receiving cavity in an axial direction, the first receiving cavity extending at least through a proximal end face of the first adjustment member; the second adjusting piece is inserted into the first accommodating cavity from the proximal end of the first adjusting piece in an axial sliding manner.

3. The suture length adjustment system capable of quantitative adjustment according to claim 2, wherein the inner wall of the first housing cavity is provided with a pair of slide guiding surfaces, and the first positioning portion comprises at least one slot opened on at least one slide guiding surface, and the slot extends along the radial direction of the first adjusting member;

the second adjusting part comprises a pair of outer wall surfaces in one-to-one correspondence with the pair of guide sliding surfaces, the second positioning part comprises an elastic clamping hook arranged on at least one of the outer wall surfaces, and the elastic clamping hook is clamped into the corresponding clamping groove to stop the relative movement between the second adjusting part and the first adjusting part.

4. The quantitatively adjustable suture length adjustment system of claim 3, wherein the direction of separation of the pair of slide guide surfaces is a first direction, and a gap is provided between the inner wall of the first receiving cavity and the second adjustment member in a second direction, the second direction being substantially perpendicular to the first direction.

5. The suture length adjustment system capable of quantitative adjustment according to claim 3, wherein the second adjustment member is hollow and is provided with a second receiving cavity along an axial direction, the second receiving cavity at least penetrates through a proximal end face of the second adjustment member, at least one outer wall face of the second adjustment member is provided with an opening communicated with the second receiving cavity at a proximal end region, and the elastic hook is arranged at the opening.

6. The quantitatively adjustable suture length adjustment system of any one of claims 1 to 5, further comprising a delivery assembly, a distal end of which is detachably connected to the adjustment assembly, the delivery assembly being adapted to deliver the adjustment assembly and to control the relative movement between the first and second adjustment members.

7. The quantitatively adjustable suture length adjustment system of claim 6, wherein the delivery assembly includes a delivery member and at least one drive member; the far end of the conveying piece is detachably connected with the second adjusting piece and is used for conveying the second adjusting piece and limiting the axial position of the second adjusting piece; the far end of the driving piece is detachably connected with the first adjusting piece and is used for conveying the first adjusting piece and driving the first adjusting piece and the second adjusting piece to move relatively.

8. The quantitatively adjustable suture length adjustment system of claim 7, wherein the delivery assembly further comprises a release member removably attached to the distal end of the delivery member, the proximal end of the second adjustment member being provided with a first attachment portion and the distal end of the release member being provided with a second attachment portion, the first attachment portion being removably attached to the second attachment portion.

9. The quantitatively adjustable suture length adjusting system according to claim 8, wherein the delivery assembly further comprises an outer sheath and a first retaining member attached to the distal end of the outer sheath, the first retaining member defining a retaining groove from a distal end surface, a bottom surface of the retaining groove defining a first through-hole extending in the axial direction for the distal end of the delivery member to pass through, the first retaining member further defining at least one second through-hole extending in the axial direction on a side of the retaining groove for the distal end of at least one of the driving members to pass through;

the conveying piece and at least one driving piece are movably arranged in the outer sheath tube in a penetrating way;

the sheath tube drives the first limiting part to move axially, so that the connecting part of the first connecting part and the second connecting part is accommodated in or moved out of the limiting groove, and the second adjusting part is connected with or separated from the releasing part.

10. The quantitatively adjustable suture length adjustment system of claim 9, wherein a radial gap is provided between the axis of the stop slot and the axis of the first stop member, the stop slot being eccentrically disposed at the distal end of the first stop member.

11. The quantitatively adjustable suture length adjustment system according to claim 10, wherein the first stop member is provided with rafters at the edges of the distal end face, the rafters extending circumferentially of the first stop member; the first adjusting piece moves to the near end along the axial direction relative to the second adjusting piece to abut against the far end face of the first limiting piece, and the protrusion surrounds the near end portion of the first adjusting piece.

12. The quantitatively adjustable suture length adjusting system according to claim 11, wherein the outer wall of the first adjusting member is provided with a first slot communicating with the first receiving cavity from a proximal end face, and the protrusion is provided with a second slot corresponding to the first slot;

when the first adjusting piece abuts against the far end face of the first limiting piece, the first open groove and the second open groove form a through hole together.

13. The quantitatively adjustable suture length adjusting system according to claim 9, wherein the releasing member is provided with a third through hole which is axially through and provided with an internal thread, corresponding to the first through hole, and the delivery member is screw-coupled to the releasing member and has a distal end protruding from a distal end of the releasing member;

the conveying assembly further comprises a second limiting part connected to the far end of the conveying part, and the conveying part is further used for driving the second limiting part to move towards the far end along the axial direction until the second limiting part is contained in the second containing cavity and corresponds to the position of the elastic clamping hook so as to stop the elastic clamping hook from bending towards the second containing cavity.

14. The quantitatively adjustable suture length adjustment system of claim 7, wherein the distal end portion of the drive member is externally threaded; the first adjusting piece is provided with threaded holes extending along the axial direction from the proximal end face to one side of the first accommodating cavity, the number of the threaded holes corresponds to that of the driving piece, and the internal threads of the threaded holes are matched with the external threads of the driving piece.

15. The quantitatively adjustable suture length adjustment system of claim 3, wherein the outer wall of the first adjustment member is open from a proximal end face with a first slot communicating with the first receiving cavity, the first slot extending substantially in an axial direction of the first adjustment member;

the positions of the first open groove and the clamping groove in the circumferential direction of the first adjusting piece are staggered.

16. The quantitatively adjustable suture length adjustment system of claim 15, wherein the distal end face of the second adjustment member opens into a radial slot corresponding to the first slot, both ends of the radial slot penetrating through the outer wall of the second adjustment member, respectively.

17. The suture length adjustment system capable of quantitative adjustment according to claim 3, wherein the outer wall of the first adjustment member is provided with at least one hollow hole, and the extending direction of the hollow hole is the same as or different from the extending direction of the clamping groove.

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